Status:
COMPLETED
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborating Sponsors:
AAI Clinic
Conditions:
To Determine Bioequivalence Under Fed Conditions
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To compare the relative bioavailability of Kali and Ortho-McNeil's products
Detailed Description
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg
Eligibility Criteria
Inclusion
- Healthy Males and females between 18 and 45 years of age inclusive
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.
Exclusion
- Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
- Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
- This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
- Tobacco use(\>5 cigarettes per day)in the 3 months prior to study dosing.
- If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
- Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
- Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
- females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2002
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00652821
Start Date
May 1 2002
End Date
August 1 2002
Last Update
September 26 2017
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